VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)— 510(k) DEN240025

Name: FDA 510(k) clearance DEN240025
Creator: U.S. Food and Drug Administration
Published: 2024-12-05

Unknown

Ventana Medical Systems, Inc.

FDA 510(k) clearance DEN240025 for VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001), Unknown on 2024-12-05. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code SDP
Device class: Class 2
Regulation: 21 CFR 864.1861
Advisory panel: Hematology
Date received: 2024-05-29
Decision date: 2024-12-05
Decision: Unknown
Clearance type: Direct
Location: Tucson, AZ, US

View on FDA.gov ↗

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